Kornimate/medical-research-clean huggingface dataset:
an investigation of premama balance and its effects on hormonal imbalances

Conditions: PMS; Menstrual Discomfort; Hormone Disturbance; Menstrual Pain; Menstrual Irregularity

Summary: an investigation of the dietary supplement marketed as "premama balance" on markers of subjective wellbeing in trial participants such as common symptoms of pms and menstrual symptoms, as well as its effects on aiding in returning to their perceived regular/normal menstrual cycle.


Eligibility criteria:
inclusion criteria: * must be in good health (don't report any medical conditions asked in the screening questionnaire) * must be on hormonal birth control (containing both progesterone and estrogen) for the past 6 months \& willing to stop using it to participate in the study * must be willing to get off of hormonal birth control for the study period * must be able to track their menstrual cycle * bmi under 40 * agree to refrain from any lifestyle changes that may affect their menstrual cycle for the duration of the study * willingness to adhere to the dietary supplement regimen * willingness to refrain from any other dietary supplements targeting the menstrual cycle and hormone control during the study period * is able to communicate in english * is willing and able to share feedback via the used technology portal * must provide written informed consent (icf) exclusion criteria: * history of oncological (including ovarian cancer) or psychiatric conditions * history of uncontrolled health conditions * history of hysterectomy or ovariectomy * history of diabetes \& thyroid disorders * smoker * more than 3 servings of alcohol a day * undergoing hormonal therapy of any kind * menopausal or peri-menopausal * not starting any other form of contraceptive other than condoms, abstinence, planned sexual intercourse * usage of any medication or herbal remedies/supplements which can affect the menstrual cycle or hormonal balance * if currently taking allowed supplements, the dosage needs to remain the same throughout the entirety of the study

Keywords: pms menstrual discomfort hormone disturbance menstrual pain menstrual irregularity
success and quality of life following complete pulpotomy and root canal treatment

Conditions: Irreversible Pulpitis

Summary: the purpose of this study is to compare the success and quality of life following complete pulpotomy and root canal treatment in teeth with clinical signs indicative of irreversible pulpitis.

after thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, risks and benefits associated with the procedure will be explained and written informed consent will be taken from the patients. study subjects will be randomly allocated to either complete pulpotomy or root canal treatment group.

Eligibility criteria:
inclusion criteria: * mature permanent restorable mandibular molar teeth. * tooth should give positive response to pulp sensibility testing. * clinical diagnosis of irreversible pulpitis with pai score≤2. * tooth with probing pocket depth and mobility are within normal limits. * non-contributory medical history. exclusion criteria: * teeth with immature roots. * no pulp exposure after caries excavation. * bleeding could not be controlled in 6 minutes. * insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic. * absence of antagonist tooth. * positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis * had taken analgesic in past 3 days. * tooth with periapical lesion visible on radiograph

Keywords: pulpitis pulpotomy single visit root canal treatment bioceramic material
a study of ly4057996 in healthy participants and participants with type 1 and type 2 diabetes

Conditions: Healthy; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: the purpose of this study is to evaluate how well ly4057996 is tolerated and what side effects may occur in healthy participants and participants with type 1 and type 2 diabetes. the study drug will be administered either subcutaneously (sc) (under the skin) or intravenously (iv) (into a vein in the arm). blood tests will be performed to check how much ly4057996 gets into the bloodstream and how long it takes the body to eliminate it. the study will last 11 weeks for part a1-a2, 4 weeks for a3-a5, 5 weeks for part b and 7 weeks for part c, all approximations, excluding a screening period.


Eligibility criteria:
inclusion criteria: part a for healthy participants: * are overtly healthy as determined by medical evaluation, including medical history, physical exam, laboratory tests, and cardiac screening assessment part a for type 2 diabetes (t2dm) participants: * are participants with t2dm diagnosed greater than 1 year before enrollment, * on basal insulin therapy, insulin glargine, or insulin degludec, greater than 10 units per day for at least 6 months (for cohort 5 only) * glycated hemoglobin (hba1c) 6.5% to 9.5% inclusive at screening part b * have type 1 diabetes (t1d) for at least 1 year with a fasting c-peptide level of 0.20 nanomole per liter (nmol/l) or less or non-fasting c-peptide level of 0.30 nmol/l or less at screening * hba1c 6% to 8.5% inclusive at screening part c * have t1d for at least 1 year with a fasting c-peptide level of 0.20 nanomole per liter (nmol/l) or less or non-fasting c-peptide level of 0.30 nmol/l or less at screening * hba1c 6 to 8% inclusive at screening all parts * have blood pressure of less than 140/90 millimeters of mercury (mmhg) for healthy participants or 150/90 mmhg for participants with diabetes and pulse rate of less than 90 beats per minute (bpm) (supine) * no hypoglycemia unawareness for all type 1 and type 2 diabetes participants exclusion criteria: * have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening * have had any episodes of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within the 6 months prior to screening all parts * cardiovascular: no significant history of cardiovascular disease (cvd) * gastrointestinal: have gastroparesis or have undergone gastric surgery * hepatic: have acute or chronic hepatitis
visual function after implantation of acrysof® toric lens

Conditions: Cataract

Summary: the objective of this study is to evaluate the postoperative visual function of taiwanese patients following bilateral or unilateral acrysof toric intraocular lens (iol) implantation.


Eligibility criteria:
inclusion criteria: * prospective subjects should be adults and may be of any race and gender, and diagnosed with cataracts. * subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens. * all subjects must have between 0.75 - 2.0 diopter (d) of astigmatism preoperatively as measured by keratometry readings. * for any second eye surgery in bilateral acrysof toric patients, it should be performed at least one week following the first eye implant but no longer than one month after the first implant. exclusion criteria: * subjects with pre-existing conditions that could skew the results should be excluded from the study. * acrysof® toric product inserts under "precautions" for subject groups that should be excluded from this study.

Keywords: cataract
endometrial biopsy protocol for in vitro fertilization (ivf)

Conditions: Infertility; Recurrent Implantation Failure

Summary: endometrial biopsy has been shown to improve ivf pregnancy and live birth rates. the optimal time of performing the biopsy is yet to be established. in this study, the investigators will compare different temporal timing of the biopsies with regards to the menstrual cycle and their affect on the success rates of the treatment.


Eligibility criteria:
inclusion criteria: * normal menstrual cycle * between 1-6 previous failed ivf cycles * normal hormonal profile exclusion criteria: * intrauterine procedure in last 3 months * hydrosalpinx * intrauterine lesion /malformation
lyophilized fecal transplant vs lyophilized fecal filtrate in recurrent c diff infection

Conditions: Enterocolitis; Recurrent Clostridium Difficile Infection

Summary: fecal microbiota transplantation (fmt) for the treatment of recurrent clostridium difficile infection (rcdi) has traditionally been offered as fecal slurry administered by enema, nasogastric tube or endoscopy. frozen oral capsules have also shown efficacy. the potential advantage of lyophilized fmt is the relative ease of manufacturing and storage compared with fecal slurry. sterile fecal filtrate has previously been shown to prevent clostridium difficile infection (cdi) recurrence, suggesting that live bacteria may not be needed. this study will compare lyophilized sterile fecal filtrate (lsff) with lyophilized fmt (lfmt) in the treatment of recurrent clostridium difficile infection (rcdi).

this prospective double blind randomized pilot study will enroll 40 subjects with recurrent clostridium difficile infection in a 1:1 ratio to receive either lsff or lfmt by capsules. subjects will receive 15 capsules at week 0 and be assessed at weeks 1, 4, 12 and 24. if treatment fails, subjects will be given open label lfmt from the same donor. if treatment fails again, another fmt will be offered and the form and route of fmt delivery will be at the discretion of the treating physician.

Eligibility criteria:
inclusion criteria: 1. at least 3 episodes of recurrent cdi, with each episode defined as 3 or more unformed stools in 24 hours associated with positive clostridium difficile toxin, each occurring within 3 months of each other. 2. cdi under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment 3. ability to provide informed consent. 4. females and males must agree to use effective contraception for the duration of the study as applicable exclusion criteria: 1. complicated cdi defined as wbc \>35, significant abdominal pain and distention, evidence of toxin megacolon or pseudomembraneous colitis, hypotension defined as systolic blood pressure \<90 mmhg unresponsive to fluid resuscitation, end organ failure, or requiring admission to intensive care. 2. chronic diarrheal illness such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission of 3 months prior to enrollment. 3. taking or planning to take an investigational drug within 3 months of enrollment. 4. immunosuppression 5. chemotherapy or radiation therapy 6. oropharyngeal or significant esophageal dysphagia 7. ileus or small bowel obstruction 8. subtotal colectomy 9. pregnancy or planning to become pregnant within 3 months of enrollment 10. breastfeeding or planning to breastfeed during the trial 11. active infection requiring antibiotic therapy. 12. life expectancy \<6 months -
lipo-prostaglandin e1 improves renal hypoxia evaluated by bold-mri in patients with diabetic nephropathy

Conditions: Diabetic Nephropathy

Summary: the purpose of this study is to evaluate the effect of lipo-prostaglandin e1 （lipo-pge1) on renal oxygenation in patients with diabetic nephropathy by blood oxygenation level dependent magnetic resonance imaging (bold-mri).patients with stable chronic kidney disease (ckd) were included. all patients were divided into two groups: diabetic nephropathy（dn) and ckd without diabetes. in addition to the conventional treatments, all patients received 10 ug lipo-pge1 intravenously once daily for consecutive 14 days. kidney bold-mri were performed before and after lipo-pge1 administration to acquire bilateral renal cortical r2\*(cr2\*) and medullary r2\* (mr2\*) values. meanwhile, the clinical indexes at baseline and under lipo-pge1 including 24 hours urinary protein and serum creatinine were collected. the investigators want to prove lipo-pge1 can improve kidney medullary oxygenation in patients with dn.

r2\* maps were calculated using the in-house software in matlab (version 7.0, the mathworks, inc., cambridge, ma, usa) on a pixel-by-pixel basis by fitting㏑(signal intensity) versus echo time. the r2\* map was windowed from 0 to 60 s-1. regions of interest (rois) with unfixed size (7 to 53 pixels) were defined at the upper, middle and lower poles of both kidneys in the medulla and cortex in the renal hilum plane based on the anatomical images. three rois were placed in the medulla and cortex, respectively, carefully avoiding vessels, renal sinus and susceptibility artifacts, yielding a total of 6 rois in both kidneys. the values in each roi were averaged for the bilateral cortex and medulla. to prevent significant bias from measurement variability, each sample was measured independently by three professional radiologists with more than 5 years of experience who were blinded to the clinical results. thereafter, assuming the tests were coincident, the results were the averaged.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic kidney disease exclusion criteria: * intolerance to lipo-pge1, contraindication for mri, concurrent urinary tract infection, acute kidney injury, acute cardiovascular and cerebrovascular complications and diabetic emergencies, with the use of corticosteroid and diureses.
oral ibrexafungerp (scy-078) vs standard-of-care following iv echinocandin in the treatment of invasive candidiasis

Conditions: Mycoses; Candidiasis, Invasive; Candidemia

Summary: the purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral scy-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis.

patients will receive initial intravenous (iv) echinocandin therapy. patients who are eligible for randomization will receive scy-078 500-mg orally, scy-078 750-mg orally, or standard-of-care.

Eligibility criteria:
inclusion criteria: * diagnosis of invasive candidiasis defined as a positive culture of blood or from another normally sterile site for candida. * not of reproductive potential or if of reproductive potential, agrees to remain abstinent or use 2 methods of contraception. exclusion criteria: * patient with candida endocarditis, osteomyelitis, meningitis, or chronic disseminated candidiasis or evidence of endophthalmitis. * patient has failed treatment with an echinocandin for this episode of invasive candidiasis. * infection limited to the oropharynx, esophagus, urogenital system, or skin, or sputum/bronchoalveolar lavage culture. * participation in a clinical study with other investigational drug(s) within 30 days prior to study entry or during this study.

Keywords: invasive candidiasis invasive candida infections candidemia scy-078 micafungin fluconazole echinocandin
safety and efficacy study of nfc-1 in subjects aged 12-17 years with 22q11.2ds & associated neuropsychiatric conditions

Conditions: 22q11.2 Deletion Syndrome

Summary: this is a 5-week, multi-center, open-label, dose optimization trial in subjects aged 12-17 years with 22q11ds who have a diagnosis of anxiety disorder, and/or adhd, and/or asd. approximately 12 subjects will be initiated, dose optimized, and maintained on nfc-1 over a period of 5 weeks.


Eligibility criteria:
inclusion criteria: * subject has a diagnosis of a 22q11.2 deletion prior to screening. * subject has a diagnosis of anxiety disorder and/or adhd and/or asd based upon diagnostic evaluations performed at screening, history, and clinical judgement. * subject is judged to be in general good health, other than having anxiety disorder and/or adhd and/or asd and 22q11ds. medical conditions related to 22q11ds must be clinically stable post surgical correction and/or medical management. * subject has no clinically significant abnormality on 12-lead electrocardiogram (ecg) performed at screening or baseline such as serious arrhythmia, bradycardia, tachycardia, cardiac conduction problems, or other abnormalities deemed to be a potential safety issue. * subject and parent/legal guardian understand the study procedures and agree to the subject's participation in the study as indicated by parental/legal guardian signature on the subject informed consent form and subject's signature on the assent form. exclusion criteria: * subject has a diagnosis of co-morbid major psychiatric disorders (ie, aside from anxiety disorder, adhd, and/or asd), including major depression, bipolar disease, schizophrenia (or any psychotic disorder), and moderate or severe intellectual disability, which in the opinion of the investigator may interfere with the conduct of study evaluations. * subject has an iq \< 65 as determined by the wechsler abbreviated scale of intelligence. * subject has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by his/her participation in the study. * subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or disease which is not currently stable clinically. subjects with a history of uncomplicated kidney stones may be enrolled in the study at the discretion of the investigator. * subject has a history of stroke, chronic seizures, or other major neurological disorder which, in the opinion of the investigator, would interfere with the subject's ability to participate and/or be evaluated in the trial. * subject is currently considered at risk for suicide (in the opinion of the investigator), has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. * subject has taken any antidepressants, antipsychotics, anxiolytics, or non-stimulant adhd medication within 30 days of the screening visit. * subject is taking a prohibited medication

Keywords: 22q11.2 ds
a research study to see how a new medicine (nnc0487-0111) works in people with overweight or obesity when injected under the skin

Conditions: Obesity; Overweight

Summary: the purpose of the study is to evaluate if a new study drug, nnc0487-0111, is safe and how it works in the participant's body, when given as injections under the skin


Eligibility criteria:
inclusion criteria: * male or female * aged 18-55 years (both inclusive) at the time of signing informed consent. * body mass index (bmi) between 27.0 and 39.9 kg/m\^2 (both inclusive) at screening. overweight should be due to excess adipose tissue, as judged by the investigator. * considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: * any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol * hba1c equal to or greater than 6.5 % (48 mmol/mol) at screening * any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values: * vitamin d (25-hydroxycholecalciferol) below 12 ng/ml (30 nm) at screening * parathyroid hormone (pth) outside normal range at screening * total calcium outside normal range at screening * amylase equal to or greater than 2 times upper limit of normal at screening * lipase equal to or greater than 2 times upper limit of normal at screening * calcitonin equal to or greater than 50 ng/l at screening
potentiating rural investment in children's eyecare (price)

Conditions: Myopia

Summary: the aim of the project is to create, study and advocate for a model that can be adopted by the chinese government to provide spectacles for all children sustainable.

uncorrected refractive error (ure) is the leading cause of visual impairment among chinese children, accounting for 90% or more of poor vision, and chinese children have among the highest rates of myopia in the world. despite the fact that the problem of ure is safely and inexpensively treated with glasses, only 15-40% of children needing them own and wear glasses sufficient to provide good vision in rural china. price (potentiating rural investment in children's eyecare) will use a randomized, controlled design across 4 groups of all 138 schools in yunnan (one of china's poorest provinces) and guangdong (one of the richest) to optimize the model of "free glasses for all with an optional upgrade." the selection of free spectacles and cost of the "upgrade" options will be varied between groups in order to find the optimal balance between high rates of purchase of upgrade glasses on the one hand and good acceptance and wear of free spectacles among those selecting them on the other.

Eligibility criteria:
inclusion criteria: 1. randomly selected primary schools, which has all 3, 4 and 5 grades, in the 9 project counties. 2. a class randomly selected from each grade of 3, 4, and 5 grades of the selected primary schools. 3. all children in the selected classes. exclusion criteria: 1. those schools that the total number of students are more than 2000. 2. those schools that the total number of students of 3, 4, 5 grades are less than 80. 3. children suffering from eye diseases such as cataract, congenital ptosis, strabismus, congenital glaucoma will not be included in the study and will be recommended referral.

Keywords: myopia prevalence proportion of purchase of free spectacles proportion of purchase of update spectacles proportion of wearing spectacles
endometrial cancer survivors' follow-up care (ensure): less is more?

Conditions: Endometrial Cancer

Summary: background: it has often been hypothesized that the frequency of follow-up for patients with early-stage endometrial cancer could be decreased. however, studies evaluating effects of a reduced follow-up schedule among this patient group are lacking. objective: assess patient satisfaction and cost-effectiveness of a less frequent follow-up schedule compared to the schedule according to the dutch guideline. study design: dutch multicentre randomized controlled trial with a 5 year follow-up. patients (n=282) are randomized in an intervention group with 4 follow-up visits during 3 years, and a control group with 10-13 follow-up visits during 5 years, according to the dutch guideline. patients are asked to fill out a questionnaire at baseline, 6, 12, 36 and 60 months. patient inclusion will take two years (if 60% of the patients participate). outcomes: primary: patient satisfaction with follow-up care and cost-effectiveness. secondary: health care use, adherence to schedule, health-related quality of life, fear of recurrence, anxiety and depression, information provision, recurrence, survival patients: stage 1a and 1b low-risk endometrial cancer patients, for whom adjuvant radiotherapy is not indicated statistics: linear regression analyses to assess differences in patient satisfaction with follow-up care between intervention and control group adjusted for potential pre-defined confounders. expected results: patients in the intervention arm have a similar satisfaction with follow-up care and overall outcomes, but lower health care use and costs than patients in the control arm. no effects are expected on qaly differences (losses) and satisfaction, but the reduced schedule is expected to save 144.000 per year in the netherlands.


Eligibility criteria:
inclusion criteria: 1. patients with endometrioïd type endometrial carcinoma with stage 1 (figo, 2009) disease, with the following combination of stage, age and grade: stage 1a, any age, grade 1 or 2; stage 1b, \< 60 years, grade 1 or 2 without lvsi; 2. written informed consent; 3. sufficient oral and written command of the dutch language. exclusion criteria: 1. any other stage and type of endometrial carcinoma 2. histological types papillary serous carcinoma or clear cell carcinoma 3. uterine sarcoma (including carcinosarcoma) 4. radiotherapy for current endometrial carcinoma 5. previous malignancy (except for non-melanomatous skin cancer) \< 5 yrs 6. confirmed lynch syndrome 7. previous pelvic radiotherapy

Keywords: follow up care satisfaction with care